MAUDE Adverse Event Report: T:90¿ INFUSION SET; INSET II 60/9 GREY

Lot Number	UNKNOWN
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that he accidentally ripped off his site, went back home to replace the site but later discovered the cannula was not inserted all the way into his skin and was kinked.He had high blood glucose level of 798 mg/dl and experienced diabetic ketoacidosis, so was admitted to the hospital.During hospitalization, he received intravenous insulin drip as corrective treatment which resolved the issue.The patient was admitted for two days and there was no permanent damage to the patient.No further information available.

• Brand Name: T:90¿ INFUSION SET
• Common Device Name: INSET II 60/9 GREY
• MDR Report Key: 8517147
• Report Number: 3003442380-2019-01167
• Device Sequence Number: 1466158
• Product Code: FPA
• UDI-Device Identifier: 05705244004450
• UDI-Public: 05705244004450
• Combination Product (Y/N): N
• PMA/510(K) Number: K032854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 04/16/2019
• Patient Sequence Number: 1